Inflatable penile prosthesis having a cylinder with a porous portion

ABSTRACT

According to an aspect, an implant includes an inflatable member and a pump assembly configured to facilitate a transfer of a fluid from the reservoir to the inflatable member. The inflatable member has a sidewall that defines a lumen and a porous structure disposed within the lumen.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a Nonprovisional of, and claims priority to, U.S.Patent Application No. 62/655,378, filed on Apr. 10, 2018, entitled“INFLATABLE PENILE PROSTHESIS HAVING A CYLINDER WITH A POROUS PORTION”,which is incorporated by reference herein in its entirety.

TECHNICAL FIELD

This disclosure relates generally to bodily implants and morespecifically to bodily implants, such as penile prostheses that includeinflatable members.

BACKGROUND

One treatment for male erectile dysfunction is the implantation of apenile prosthesis that mechanically erects the penis. Some existingpenile prostheses include inflatable cylinders or members that can beinflated or deflated using a pump mechanism. In some existing devices,the inflatable cylinder or member requires a relatively large amount offorce to inflate. Additionally, in some existing devices, the pumpmechanism may require many sequential squeezes or activations to inflatethe cylinder or member. Furthermore, in some existing devices, theinflatable cylinder or member may assume a flat, unnatural shape when ina deflated configuration.

Accordingly, it would be useful to provide a bodily implant, such as apenile prosthesis, that includes an improved cylinder or member that canbe more easily inflated. Additionally, it would be useful to provide abodily implant, such as a penile prosthesis, that includes an inflatablecylinder or member that may assume a natural shape when in the deflatedconfiguration.

SUMMARY

According to an aspect, an implant includes an inflatable member and apump assembly configured to facilitate a transfer of a fluid from thereservoir to the inflatable member. The inflatable member has a sidewallthat defines a lumen and a porous structure disposed within the lumen.

In some embodiments, the porous structure defines a plurality ofcavities. In some embodiments, the inflatable member defines alongitudinal axis, the porous structure extends along the longitudinalaxis. In some embodiments, the sidewall includes an outer surface, theouter surface of the sidewall is substantially smooth.

In some embodiments, the inflatable member is configured to be placed inan inflated configuration and a deflated configuration. In someembodiments, the inflatable member is configured to be placed in aninflated configuration and a deflated configuration, the inflatablemember having a tubular shape when in the deflated configuration. Insome embodiments, the inflatable member is configured to be placed in aninflated configuration and a deflated configuration, the inflatablemember having a tubular shape when in the inflated configuration. Insome embodiments, the inflatable member is configured to be placed in aninflated configuration and a deflated configuration, the inflatablemember having a tubular shape when in the deflated configuration andhaving a tubular shape when in the inflated configuration.

In some embodiments, the inflatable member is configured to be placed inan inflated configuration and a deflated configuration, the inflatablemember configured to extend along a longitudinal axis of the inflatablemember when placed in the inflated configuration. In some embodiments,the inflatable member is configured to be placed in an inflatedconfiguration and a deflated configuration, the inflatable memberconfigured to extend in a direction transverse to a longitudinal axis ofthe inflatable member when placed in the inflated configuration.

In some embodiments, the porous structure defines a plurality ofcavities, the fluid being configured to be disposed within the pluralityof cavities when the inflatable member is placed in an inflatedconfiguration.

In some embodiments, the implant includes a first cap coupled to a firstend portion of the sidewall and a second cap coupled to a second endportion of the sidewall.

In some embodiments, the implant includes a first cap coupled to a firstend portion of the sidewall and a second cap coupled to a second endportion of the sidewall. The porous structure being disposed between thefirst cap and the second cap.

In some embodiments, the implant includes a reservoir configured toretain the fluid, and the pump is configured to help facilitate atransfer of the fluid from the reservoir to the inflatable member whenthe implant is in an inflation mode.

In some embodiments, the pump assembly includes a valve body and a pumpbulb member.

According to another aspect, a method, includes disposing a firstmaterial within a lumen of a sheath; disposing a second material withinthe lumen of the sheath, the second material being different than thefirst material; and removing the first material from with lumen of thesheath while leaving the second material disposed within the sheath.

In some embodiments, the first material is water-soluble, the secondmaterial is non-soluble in water. In some embodiments, the removing thefirst material from the lumen includes passing a liquid through thelumen of the sheath.

In some embodiments, the second material is disposed within the lumen ofthe sheath after the first material is disposed within the sheath.

In some embodiments, the method includes disposing tubular memberswithin the lumen of the sheath.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 schematically illustrates a penile prosthesis according to anembodiment.

FIG. 2 illustrates a penile prosthesis according to another embodiment.

FIG. 3 illustrates the penile prosthesis of FIG. 2 implanted within apatient according to an embodiment.

FIG. 4 is a cross-sectional view of the cylinder or inflatable member ofthe penile prosthesis of FIG. 2.

FIG. 5 is an end view of the cylinder or inflatable member of the penileprosthesis of FIG. 2.

FIGS. 6-10 illustrate cylinder or inflatable member being formedaccording to an embodiment.

FIG. 11 is a flow chart of a method of making a cylinder or inflatablemember of a penile prosthesis according to an embodiment.

DETAILED DESCRIPTION

Detailed embodiments are disclosed herein. However, it is understoodthat the disclosed embodiments are merely examples, which may beembodied in various forms. Therefore, specific structural and functionaldetails disclosed herein are not to be interpreted as limiting, butmerely as a basis for the claims and as a representative basis forteaching one skilled in the art to variously employ the embodiments invirtually any appropriately detailed structure. Further, the terms andphrases used herein are not intended to be limiting, but to provide anunderstandable description of the present disclosure.

The terms “a” or “an,” as used herein, are defined as one or more thanone. The term “another,” as used herein, is defined as at least a secondor more. The terms “including” and/or “having”, as used herein, aredefined as comprising (i.e., open transition). The term “coupled” or“moveably coupled,” as used herein, is defined as connected, althoughnot necessarily directly and mechanically.

In general, the embodiments are directed to medical devices such aspenile prostheses or other bodily implants. The term patient or user mayhereafter be used for a person who benefits from the medical device orthe methods disclosed in the present disclosure. For example, thepatient can be a person whose body is implanted with the medical deviceor the method disclosed for operating the medical device by the presentdisclosure. For example, in some embodiments, the patient may be a humanmale, a human female, or any other mammal.

The embodiments discussed herein may improve the performance of aninflatable member of the device. For example, the inflatable member mayhave improved stiffness or rigidity, improved reliability, or improveddeflation or inflation times. In some embodiments, inflating theinflatable member may be facilitated by requiring less force, lesspressure, or less fluid transfer to inflate the inflatable member.Additionally, in some embodiments, the inflatable member may retain ormaintain a tubular shape when the inflatable member is placed in itsdeflated configuration.

The embodiments may include an inflatable penile prosthesis having apump assembly, an inflatable member, and a reservoir. The inflatablemember may be implanted into the corpus cavernosae of a patient or user,the reservoir may be implanted in the user's abdomen, and the pumpassembly may be implanted in the scrotum. The pump assembly may switchbetween an inflation position and a deflation position such that a usercan operate the device to place the inflatable penile prosthesis ineither an inflation mode to transfer fluid from the reservoir to theinflatable member or a deflation mode to transfer the fluid from theinflatable member back to the reservoir.

FIG. 1 schematically illustrates an inflatable penile prosthesis 100according to an aspect. The inflatable penile prosthesis 100 may includea reservoir 102, a cylinder or inflatable member 104, and a pumpassembly 101 configured to transfer fluid between the reservoir 102 andthe inflatable member 104. In some examples, the inflatable member 104may be implanted into the corpus cavernosae of the user, the reservoir102 may be implanted in the abdomen or pelvic cavity of the user (e.g.,the reservoir 102 may be implanted in the lower portion of the user'sabdominal cavity or the upper portion of the user's pelvic cavity), andthe pump assembly 101 may be implanted in the scrotum of the user.

The inflatable member 104 may be capable of expanding upon the injectionof fluid into a cavity of the inflatable member 104. For instance, uponinjection of the fluid into the inflatable member 104, the inflatablemember 104 may increase its length and/or width, as well as increase itsrigidity. In some examples, the inflatable member 104 may include a pairof cylinders or at least two cylinders, e.g., a first cylinder memberand a second cylinder member. The volumetric capacity of the inflatablemember 104 may depend on the size of the cylinders. In some examples,the volume of fluid in each cylinder may vary from about 10 millilitersin smaller cylinders and to about 50 milliliters in larger sizes. Insome examples, the first cylinder member may be larger than the secondcylinder member. In other examples, the first cylinder member may havethe same size as the second cylinder member.

In some embodiments, the inflatable member 104 or cylinder includes asidewall, an outer sheath or tubular member and an internal structuralmember. In some embodiments, the outer sheath or tubular member of theinflatable member 104 defines a lumen and the structural member isdisposed within the lumen.

In some embodiments, the structural member is porous such that it isconfigured to allow a fluid to pass through it. In some embodiments, thestructural member defines a series or a plurality of cavities and/orchannels. In some embodiments, the structural member includes asponge-like structure.

In some embodiments, the inflatable member 104 includes end caps or endtip members. The end tip members may be coupled to the end portions ofthe outer sheath. In some embodiments, the structural member is disposedwithin the lumen defined by the outer sheath and is disposed between theend caps or end tip members.

In some embodiments, the structural member may allow the inflatablemember to be inflated at a relatively low pressure. In some embodiments,this may allow the user to inflate the inflatable member 104 with lesspumps or activations of the pump or may allow the user to apply lessforce to the pump to inflate the inflatable member 104. Details of thepump assembly 101 are described below. Additionally, in someembodiments, the structural member of the inflatable member 104 mayallow the inflatable member 104 to retain or maintain a tubular shape(or a more anatomically correct shape) when the inflatable member 104 isin its deflated configuration.

The reservoir 102 may include a container having an internal chamberconfigured to hold or house fluid that is used to inflate the inflatablemember 104. The volumetric capacity of the reservoir 102 may varydepending on the size of the inflatable penile prosthesis 100. In someexamples, the volumetric capacity of the reservoir 102 may be 3 to 150cubic centimeters. In some examples, the reservoir 102 is constructedfrom the same material as the inflatable member 104. In other examples,the reservoir 102 is constructed from a different material than theinflatable member 104.

The inflatable penile prosthesis 100 may include a first conduitconnector 103 and a second conduit connector 105. Each of the firstconduit connector 103 and the second conduit connector 105 may define alumen configured to transfer the fluid to and from the pump assembly101. The first conduit connector 103 may be coupled to the pump assembly101 and the reservoir 102 such that fluid can be transferred between thepump assembly 101 and the reservoir 102 via the first conduit connector103. For example, the first conduit connector 103 may define a firstlumen configured to transfer fluid between the pump assembly 101 and thereservoir 102. The first conduit connector 103 may include a single ormultiple tube members for transferring the fluid between the pumpassembly 101 and the reservoir 102.

The second conduit connector 105 may be coupled to the pump assembly 101and the inflatable member 104 such that fluid can be transferred betweenthe pump assembly 101 and the inflatable member 104 via the secondconduit connector 105. For example, the second conduit connector 105 maydefine a second lumen configured to transfer fluid between the pumpassembly 101 and the inflatable member 104. The second conduit connector105 may include a single or multiple tube members for transferring thefluid between the pump assembly 101 and the inflatable member 104. Insome examples, the first conduit connector 103 and the second conduitconnector 105 may include a silicone rubber material.

The pump assembly 101 may switch between an inflation mode in which thefluid in the reservoir 102 is transferred to the inflatable member 104through the pump assembly 101 in a first direction (e.g., inflationdirection) and a deflation mode in which the fluid in the inflatablemember 104 is transferred back to the reservoir 102 through the pumpassembly 101 in a second direction (e.g., deflation direction).

The pump assembly 101 includes a pump (also referred to as a pump bulbmember) 106 and a valve body 107. The valve body 107 also includes aselection member 109. The selection member 109 may be used to select orchange the mode in which the pump assembly is in. For example, theselection member 109 may be moved from a first position to a secondposition to place the device in its deflation mode. The selection member109 may then be moved back to its first position to place the device inits inflation mode. In some embodiments, the selection member 109 ismovable with respect to the valve body 107. For example, in someembodiments, the selection member 109 is slidably coupled or slideablewith respect to the valve body 107.

The pump 106 may be squeezed or depressed by the user in order tofacilitate the transfer of fluid from the reservoir 102 to theinflatable member 104. For example, in the inflation mode, while theuser is operating the pump 106, the pump 106 may receive the fluid fromthe reservoir 102, and then output the fluid to the inflatable member104. When the user switches to the deflation mode, at least some of thefluid can automatically be transferred back to the reservoir 102 (due tothe difference in pressure from the inflatable member 104 to thereservoir 102). Then, the user may squeeze the inflatable member 104 tofacilitate the further transfer of fluid through the pump 106 to thereservoir 102.

In some examples, the pump 106 may include a flexible member defining acavity. In some examples, the pump 106 may define a pump shell having aflexible bulb and a valve body connector, where the valve body connectoris designed to fit at least partially over the valve body 107. In someexamples, the pump 106 may include a squeeze pump. In some examples, thepump 106 may include a portion that is round or substantially round. Insome examples, the pump 106 may include ribbing or dimples to aid theuser in gripping the pump 106. The pump 106 may use suction and pressureto move the fluid in and out of the cavity of the pump 106 in theinflation mode. For example, the user may depress or squeeze the pump106 to expel the fluid out of the cavity, and, when the flexible memberreturns to its original shape, the resulting suction pushes the fluidinto the cavity of the pump 106. In some examples, the pump 106 may havea bulb spring rate that is designed to refill the pump 106 in a selectedtime frame.

As discussed above, the selection member 109 may be used to select orchange the mode in which the pump assembly is in. For example, in oneembodiment, the selection member 109 may be placed in the inflateposition and the user may then operate the pump 106 to inflate theinflatable member 104 (i.e., move the fluid from the reservoir 102 tothe inflatable member 104). For example, the user may repeatedly depressor squeeze the pump 106 until the desired rigidity is achieved.

In some examples, if the reservoir 102 is at least partiallypressurized, the fluid may automatically flow out of the reservoir 102and into the inflatable member 104 without the user depressing orsqueezing the pump 106 until the pressure is at least partiallyequalized between the reservoir 102 and the inflatable member 104.

Then, when the user wants to deflate the inflatable member 104, the usermoves selection member 109 to its deflated position. The user may thenoperate the pump 106 to deflate the inflatable member 104 (i.e., movethe fluid from the inflatable member 104 to the reservoir 102). The pump106 may then return to its original form, which provides a suction forcecausing fluid to be drawn into the pump 106 from the inflation member104. The fluid from the inflation member 104 fills the pump 106 (or atleast partially fills the pump 106). This pump cycle is repeated untilthe inflatable member 104 is deflated.

In some examples, the fluid may automatically (upon movement of theselection member 109 to its deflate position) flow out of the inflatablemember 104 and into the reservoir 102 without the user depressing orsqueezing the pump 106 until the pressure is at least partiallyequalized between the reservoir 102 and the inflatable member 104.

In some examples, after the inflation member 104 has been deflated, thepump 106 may be squeezed to place the pump in a contracted position orconfiguration.

FIG. 2 illustrates a penile prosthesis 200 according to an aspect. FIG.3 schematically illustrates the penile prosthesis 200 placed within abody of the user or patient.

The penile prosthesis 200 may include a pair of cylinders 204, and thepair of cylinders or inflatable members 204 are implanted in a penis214. For example, one of the cylinders 204 may be disposed on one sideof the penis 214. The other cylinder 204 (not shown in FIG. 3) of thepair of cylinders may be disposed on the other side of the penis 214.The cylinder 204 may include a second end portion 224, a cavity orinflation chamber 222, and a first end portion 228 having a rear tip232.

The penile prosthesis 200 may include a pump assembly 201, which may beimplanted into the patient's scrotum 218. A pair of conduit connectors205 may attach the pump assembly 201 to the pair of inflatable membersor cylinders 204 such that the pump assembly 201 is in fluidcommunication with the pair of inflatable members or cylinders 204.Also, the pump assembly 201 may be in fluid communication with areservoir 202 via a conduit connector 203. The reservoir 202 may beimplanted into the user's abdomen 219. The inflation chamber or portion222 of the cylinder 204 may be disposed within the penis 214. The secondend portion 224 of the cylinder 204 may be at least partially disposedwithin the crown portion 226 or glands of the penis 214. The first endportion 228 may be implanted into the patient's pubic region PR with therear tip 232 proximate the pubic bone PB.

In order to implant the inflatable members or cylinders 204, the surgeonfirst prepares the patient. The surgeon often makes an incision in thepenoscrotal region, e.g., where the base of the penis 214 meets with thetop of the scrotum 218. From the penoscrotal incision, the surgeon maydilate the patient's corpus cavernosae 240 to prepare the patient toreceive the pair of inflatable members or cylinders 204. The corpuscavernosum is one of two parallel columns of erectile tissue forming thedorsal part of the body of the penis 214, e.g., two slender columns thatextend substantially the length of the penis 214. The surgeon will alsodilate two regions of the pubic area (first corpora cavernosae) toprepare the patient to receive the first end portion 228. The surgeonmay measure the length of the first and second corpora cavernosae fromthe incision and the dilated region of the pubic area to determine anappropriate size of the inflatable members or cylinders 204 to implant.

After the patient is prepared, the penile prosthesis 200 is implantedinto the patient. The second tip of the second end portion 224 of eachcylinder 204 may be attached to a suture. The other end of the suturemay be attached to a needle member (e.g., Keith needle). The needlemember is inserted into the incision and into the dilated corpuscavernosum. The needle member is then forced through the crown or glandsof the penis 226. The surgeon tugs on the suture to pull the cylinder204 into the corpus cavernosum. This is done for each cylinder of thepair of cylinders 204. Once the inflation chamber 222 is in place, thesurgeon may remove the suture from the second tip. The surgeon theninserts the first end portion 228. The surgeon inserts the rear end ofthe cylinder 204 into the incision and forces the first end portion 228toward the pubic bone PB until each cylinder 204 is in place.

In the illustrated embodiment, each of the inflatable members orcylinders 204 is structurally and functionally similar. Accordingly,only one of the inflatable members or cylinders will be discussed indetail.

FIG. 4 is a cross-sectional view of the cylinder or inflatable member204. FIG. 5 is an end view of the cylinder or inflatable member 204.

The inflatable member 204 may be capable of expanding upon the injectionof fluid into a cavity of the inflatable member 204. For instance, uponinjection of the fluid into the inflatable member 204, the inflatablemember 204 may increase its length and/or width, as well as increase itsrigidity. The volumetric capacity of the inflatable member 204 maydepend on the size of the cylinders. In some examples, the volume offluid in each cylinder may vary from about 10 milliliters in smallercylinders and to about 50 milliliters in larger sizes.

In the illustrated embodiment, the inflatable member or cylinder 204includes a sidewall, an outer sheath or tubular member 292 and aninternal structural member 294. The outer sheath or tubular member 292of the inflatable member 204 defines a lumen 293 and the structuralmember 294 is disposed within the lumen 293.

In the illustrated embodiment, the structural member 294 is porous suchthat it is configured to allow a fluid to pass through it. In theillustrated embodiment, the structural member 294 defines a series or aplurality of cavities and/or channels 295. The cavities and/or channels295 are configured to allow passage of fluid through the structuralmember 294 and thus through the lumen 293 of the tubular member 292. Insome embodiments, the structural member includes a sponge-likestructure.

In the illustrated embodiment, the inflatable member or cylinder 204includes a second end portion or tip member 224 and a first end portionor tip member 232. The tip members 224 and 232 are coupled to the endportions of the outer sheath or tubular member 292. In the illustratedembodiment, the structural member 294 is disposed between the tipmembers 224 and 232.

In some embodiments, the structural member 294 may allow the inflatablemember 204 to be inflated at a relatively low pressure. In someembodiments, this may allow the user to inflate the inflatable member204 with less pumps or activations of the pump or may allow the user toapply less force to the pump to inflate the inflatable member 204.Details of the pump assembly 201 are described below. Additionally, insome embodiments, the structural member 294 of the inflatable member 204may allow the inflatable member 204 to retain or maintain a tubularshape (or a more anatomically correct shape) when the inflatable member204 is in its deflated configuration.

In the illustrated embodiment, the outer sheath 292 includes an outersurface 296 that is smooth. In other embodiments, the outer surface 296includes grooves or ridges or is otherwise not smooth. In theillustrated embodiment, the outer sheath 292 has a thickness T. In someembodiment, the thickness T is less or smaller than a radius of theouter sheath 292.

In some embodiments, the outer sheath 292 is formed or silicone,urethane or a thermoplastic elastomer. In other embodiments, the outersheath 292 is formed of another biocompatible material. In someembodiments, the structural member 294 is formed of a low durometersilicone, urethane, or a thermoplastic elastomer. In other embodiments,the structural member 294 is formed of another biocompatible material.

The pump assembly 201 may switch between an inflation mode in which thefluid in the reservoir 202 is transferred to the inflatable member 204(or inflatable members) through the pump assembly 201 in a firstdirection (e.g., inflation direction) and a deflation mode in which thefluid in the inflatable member 204 (or inflatable members) istransferred back to the reservoir 202 through the pump assembly 201 in asecond direction (e.g., deflation direction).

The pump assembly 201 includes a pump bulb member or pump 231, a valvebody 233, and a selection member 239. The selection member may be usedto select or change the mode in which the pump assembly 201 is in. Forexample, the selection member 239 may be moved from a first position toa second position to place the device in its deflation mode. Theselection member 239 may then be moved back to its first position toplace the device in its inflation mode. In some embodiments, theselection member 239 is movable with respect to the valve body 233. Forexample, the selection member 239 may be slidably coupled or slideablewith respect to the valve body 233. In some embodiments, the selectionmember 239 includes stop members, such as shoulders or detents thatengage members of the valve body 233 to lock or help retain theselection member 239 in one of its first and second positions. In otherembodiments, the selection member 239 may be disposed or coupled toanother portion of the device.

The pump 231 may be squeezed or depressed by the user in order tofacilitate the transfer of fluid from the reservoir 202 to theinflatable member 204. For example, in the inflation mode, while theuser is operating the pump 231, the pump 231 may receive the fluid fromthe reservoir 202, and then output the fluid to the inflatable member204. When the user switches to the deflation mode, at least some of thefluid can automatically be transferred back to the reservoir 202 (due tothe difference in pressure from the inflatable member 204 to thereservoir 202). Then, the user may squeeze the inflatable member 204 tofacilitate the further transfer of fluid through the pump 231 to thereservoir 202.

Then, when the user wants to deflate the inflatable members 204, theuser moves selection member 239 to its deflated position. The user maythen operate the pump 231 to deflate the inflatable members 204 (i.e.,move the fluid from the inflatable members 204 to the reservoir 202).For example, the user may repeatedly depress or squeeze the pump 231until the deflation is completed. The pump 231 may then return to itsoriginal form, which provides a suction force causing fluid to be drawninto the pump 231 from the inflation members 204. The fluid from theinflation members 204 fills the pump 231 (or at least partially fillsthe pump 231). This pump cycle is repeated until the inflatable members204 are deflated.

In some examples, the fluid may automatically (upon movement of theselection member 239 to its deflate position) flow out of the inflatablemember 204 and into the reservoir 202 without the user depressing orsqueezing the pump 231 until the pressure is at least partiallyequalized between the reservoir 202 and the inflatable member 204.

In some examples, after the inflation member 204 has been deflated, thepump 231 may be squeezed to place the pump in a contracted position orconfiguration.

FIGS. 6-10 illustrate cylinder or inflatable member being formedaccording to an embodiment. FIGS. 6 and 7 illustrate an outer sheathmember 392. The outer sheath member 392 is a tubular member that definesa lumen. The lumen is filled or packed with a material. In someembodiments, the lumen is filled with a material that is water-soluble.For example, the lumen may be filled with salt or wax particles. Inother embodiments, the lumen is packed or filled with a differentwater-soluble material. As illustrated in FIG. 6 the sheath member 392is filled with fine particles of salt 397. As illustrated in FIG. 7, thesheath member 392 is filled with coarse salt particles 399.

In some embodiments, once the lumen is filled with the water-solublematerial, elongate members 281 are inserted into the lumen. Asillustrated in FIG. 8, a plurality of elongate members 281 are insertedinto the lumen such that the elongate members extend along or in thesame direction as the longitudinal axis of the sheath 292. The elongatemembers 281 are surrounded by the water-soluble material (such as thesalt). In some embodiments, the elongate members 281 facilitate theremoval of the salt. Specifically, after the elongate members 281 aredisposed within the lumen, the material of the structural member may beinjected or inserted into the lumen. Once the material of the structuralmember has hardened, the elongate members 281 can be removed from thelumen. Water or another fluid, can then be passed through the lumen,including through the spaces or channels where the elongate members 281were located. As the water passes through the lumen, the water-solublematerial will also exit the lumen, leaving just the structural memberdisposed within the lumen. FIG. 9 is a perspective view of the sheathmember 292 and the structural member 294 disposed within the lumen ofthe sheath member 292.

FIG. 10 is a cross-sectional view of the outer sheath 292 with saltcrystals disposed within the lumen of the outer sheath 292.

FIG. 11 is a flow chart of a method 400 of forming an inflatable memberaccording to an embodiment. At 410, a first material is disposed withina lumen of a sheath or elongate member. At 420, a second material isdisposed within the lumen of the sheath or elongate member. In someembodiments, the second material is different than the first material.In some embodiments, the first material is a water-soluble material. At430, the first material is removed from the lumen. In some embodiments,the second material remains within the lumen after the first material isremoved.

While certain features of the described implementations have beenillustrated as described herein, many modifications, substitutions,changes and equivalents will now occur to those skilled in the art. Itis, therefore, to be understood that the appended claims are intended tocover all such modifications and changes as fall within the scope of theembodiments.

What is claimed is:
 1. An implant, comprising: an inflatable member; anda pump assembly configured to facilitate a transfer of a fluid from thereservoir to the inflatable member, the inflatable member having asidewall that defines a lumen and a porous structure disposed within thelumen.
 2. The implant of claim 1, wherein the porous structure defines aplurality of cavities.
 3. The implant of claim 1, wherein the inflatablemember defines a longitudinal axis, the porous structure extends alongthe longitudinal axis.
 4. The implant of claim 1, wherein the sidewallincludes an outer surface, the outer surface of the sidewall issubstantially smooth.
 5. The implant of claim 1, wherein the inflatablemember is configured to be placed in an inflated configuration and adeflated configuration.
 6. The implant of claim 1, wherein theinflatable member is configured to be placed in an inflatedconfiguration and a deflated configuration, the inflatable member havinga tubular shape when in the deflated configuration.
 7. The implant ofclaim 1, wherein the inflatable member is configured to be placed in aninflated configuration and a deflated configuration, the inflatablemember having a tubular shape when in the inflated configuration.
 8. Theimplant of claim 1, wherein the inflatable member is configured to beplaced in an inflated configuration and a deflated configuration, theinflatable member having a tubular shape when in the deflatedconfiguration and having a tubular shape when in the inflatedconfiguration.
 9. The implant of claim 1, wherein the inflatable memberis configured to be placed in an inflated configuration and a deflatedconfiguration, the inflatable member configured to extend along alongitudinal axis of the inflatable member when placed in the inflatedconfiguration.
 10. The implant of claim 1, wherein the inflatable memberis configured to be placed in an inflated configuration and a deflatedconfiguration, the inflatable member configured to extend in a directiontransverse to a longitudinal axis of the inflatable member when placedin the inflated configuration.
 11. The implant of claim 1, wherein theporous structure defines a plurality of cavities, the fluid beingconfigured to be disposed within the plurality of cavities when theinflatable member is placed in an inflated configuration.
 12. Theimplant of claim 1, further comprising: a first cap coupled to a firstend portion of the sidewall; and a second cap coupled to a second endportion of the sidewall.
 13. The implant of claim 1, further comprising:a first cap coupled to a first end portion of the sidewall; and a secondcap coupled to a second end portion of the sidewall, the porousstructure being disposed between the first cap and the second cap. 14.The implant of claim 1, further comprising: a reservoir configured toretain the fluid, wherein the pump is configured to help facilitate atransfer of the fluid from the reservoir to the inflatable member whenthe implant is in an inflation mode.
 15. The implant of claim 1, whereinthe pump assembly includes a valve body and a pump bulb member.
 16. Amethod, comprising: disposing a first material within a lumen of asheath; disposing a second material within the lumen of the sheath, thesecond material being different than the first material; and removingthe first material from with lumen of the sheath while leaving thesecond material disposed within the sheath.
 17. The method of claim 16,wherein the first material is water-soluble, the second material isnon-soluble in water.
 18. The method of claim 16, wherein the removingthe first material from the lumen includes passing a liquid through thelumen of the sheath.
 19. The method of claim 16, wherein the secondmaterial is disposed within the lumen of the sheath after the firstmaterial is disposed within the sheath.
 20. The method of claim 16,further comprising: disposing tubular members within the lumen of thesheath.